Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126984
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2005-08-04
Brief Title:
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Open Partially Double-blind Randomized Controlled Dose-range Study to Evaluate the Immunogenicity Reactogenicity and Safety of Investigational Vaccination Regimens Versus MENINGITEC or MENCEVAX ACWY When Given as One Dose to Children Aged 12 to 14 Months and 3 to 5 Years Old
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the immunogenicity safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years The selection of the best formulation will be based on data obtained up to one month after the vaccine dose The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
Detailed Description:
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age Meningitec or Mencevax ACWY vaccine will serve as active control The study will be conducted in two stages The primary vaccination phase Study Stage 1 of the study will include all subjects the second boosterpersistence phase of the study Study Stage 2 will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 104704 | OTHER | GSK | None |